Label at a glance#

ProductNIGHTTIME SLEEP-AID

Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE

Label structure13 sections

Indications and uses

for the relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep

Dosage and administration

take only one dose per day (24 hours) - see Overdose warning use dose cup mL = milliliter adults & children 12 yrs & over One Dose = 30 mL at bed time if needed or as directed by a doctor Other information each 30 mL dose contains: sodium 23 mg store at room temperature protect from light. Does not meet USP .

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-855-274-4122

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (In each 30 mL dose cup)

Diphenhydramine HCl, USP 50 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Uses

INDICATIONS & USAGE SECTION

for the relief of occasional sleeplessness
reduces time to fall asleep if you have difficulty falling asleep

Do not use

OTC - DO NOT USE SECTION

for children under 12 years of age
with any other product containing diphenhydramine, even one used on skin
with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products
Do not use this product with an antihistamine and/or cough suppressant

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

a breathing problem such as asthma, emphysema, or chronic bronchitis
glaucoma
difficulty in urination due to enlargement of the prostate gland
heart disease

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers or any other sleep aid

When using this product

OTC - WHEN USING SECTION

avoid alcoholic beverages and other drugs that cause drowsiness
drowsiness will occur
be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

OTC - STOP USE SECTION

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

take only one dose per day (24 hours) - see Overdose warning
use dose cup
mL = milliliter

adults & children 12 yrs & over

One Dose = 30 mL at bed time if needed or as directed by a doctor

Other information

each 30 mL dose contains: sodium 23 mg
store at room temperature
protect from light. Does not meet USP <671>.

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, ethanol, FD&C blue #1, FD&C red #40, flavor, high fructose corn syrup, polyoxyl 40 stearate, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate dihydrate.

Questions or Comments

1-855-274-4122

Failure to follow these warnings could result in serious consequences.
Do not use if printed shrinkband is missing or broken.

* This product is not manufactured or distributed by Procter & Gamble distributor of Vicks^® ZzzQuil^® NIGHTTIME SLEEP-AID.

Distributed by:
Aurohealth LLC.
2572 Brunswick Pike,
Lawrenceville, NJ 08648

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 12 FL OZ (354 mL Bottle)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58602-520-16

Primary Health

COMPARE TO Vicks® ZzzQuil®
NIGHTTIME SLEEP-AID
active ingredient*
Nighttime
Sleep-aid

Diphenhydramine HCl

Non-Habit Forming

Not for treating Cold or Flu
See Warnings

Alcohol 10%

Warming Berry Flavor

12 FL OZ (354 mL)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 12 FL OZ (354 mL Bottle)

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1248354	diphenhydrAMINE (Oral Liquid)	diphenhydramine hydrochloride 1.67 MG/ML Oral Solution	SCD Active

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NIGHTTIME SLEEP-AID
Diphenhydramine Hydrochloride
DIPHENHYDRAMINE
ANHYDROUS CITRIC ACID
ALCOHOL
FD&C BLUE NO. 1
FD&C RED NO. 40
HIGH FRUCTOSE CORN SYRUP
POLYOXYL 40 STEARATE
PROPYLENE GLYCOL
WATER
SACCHARIN SODIUM
SODIUM BENZOATE
TRISODIUM CITRATE DIHYDRATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
58602-520	58602-520-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DIPHENHYDRAMINE HYDROCHLORIDE	TC2D6JAD40	ACTIB
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
ALCOHOL	3K9958V90M	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
HIGH FRUCTOSE CORN SYRUP	XY6UN3QB6S	IACT
POLYOXYL 40 STEARATE	13A4J4NH9I	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
TRISODIUM CITRATE DIHYDRATE	B22547B95K	IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
df93ee63-f702-40ee-80bb-c9a742ed3f84			d8330af2-076a-402c-b52d-fe99dbb30222	2020-11-26	Warnings	Exact identifier spl id: df93ee63-f702-40ee-80bb-c9a742ed3f84 spl set id: d8330af2-076a-402c-b52d-fe99dbb30222

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NIGHTTIME SLEEP-AID